Regulatory Affairs Specialist 2

Senior Regulatory Officer Industry: Medical Device Department: Regulatory Affairs Role Summary – Major Activities: 1. Provide coaching and support to all employees on the regulatory team. 2. Ensure employees understand their duties/delegated tasks. 3. Prepare and maintain IVDR compliant technical files utilising information from cross functional...

Overview The Manufacturing Engineer 2, New Product Introduction will be responsible for key activities within New Product Introduction. Key activities will include leading projects to either introduce new products or support and improve existing products. More specific details are listed below. Reporting to: Manager, Manufacturing Engineering...

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 1. Execute cycle development, cleaning validation and PQ of equipment. 2. Writing and adhering to...

Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...

360 Search are delighted to recruiting for a Group Pensions Specialist opportunity with a highly regarded Financial Service broker based in the Mid-West. Our client is hugely experienced in all areas of Personal Financial Planning, as well as having the necessary qualifications required to provide advice to all new and existing clients. Their aim is...

Our client, a leading global medical devices company, is now seeking a Chemist to join their team in Limerick. The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices, specifically providing oversight in method...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

The Principal GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will beresponsible for providing specialised knowledge and expertise in the design of (DG) frameworks, policies and procedures that are aligned with...

Overview The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU) This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company's corrective and preventive action...

Tipperary, Ireland | Posted on 12/02/2024 - Industry: Pharma/Biotech/Clinical Research - Work Experience: 1-3 years - Country: Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US,...

The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory...

Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification...

The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. Plans, coordinates, and participates in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory...

Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

Our client is seeking a highly motivated and customer-focused individual to join their team as a Level 1 Technical Support Specialist. The ideal candidate will possess excellent communication skills, a strong technical aptitude, and a passion for helping others resolve technical issues. As a Level 1 Technical Support Specialist, you will be the first point...

Overview The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues,...

Overview The Customer Support and Tender Representative 1 is responsible for providing a professional, friendly and efficient service to Cook Medical Customers, Sales Teams and / or Distribution Partners (DPs) throughout the world covering all aspects of support including Customer Service, Tender Coordination and Finance Administration as required -...

Our client is an industry-leading financial services company and they currently have an exciting opportunity for a AML Onboarding Specialist to join their Limerick based team. The AML Client Onboarding team supports the Relationship Management community globally in ensuring that onboarding procedures are followed, and accurate and complete AML/KYC...